EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE- mineral oil and petrolatum ointment

Equate Restore PM Nighttime Lubricant Eye by

Drug Labeling and Warnings

Equate Restore PM Nighttime Lubricant Eye by is a Otc medication manufactured, distributed, or labeled by Wal-Mart Stores, Inc., Altaire Pharmaceuticals, Inc.. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

SPL UNCLASSIFIED SECTION

Equate

Restore PM Nighttime Lubricant Eye Ointment

49035-191-50

                       

Drug Facts

Active ingredients

Mineral Oil 42.5% and White Petrolatum 57.3%

Purpose

Eye Lubricant

Uses

for the temporary relief of burning, irritation and discomfort due to dryness of the eye.

 exposure to wind or sun

may be used as a protectant against further irritation.

Warnings

For use in the eyes only.  Save box for complete information.

When using this product 

avoid contamination, do not touch tip of container to any surface.

replace cap after use.

Stop use and ask a doctor if

you experience eye pain, changes in vision, continued redness or irritation of the eye.

condition worsens for persists for more than 72 hours.

If pregnant or breast feeding,

ask a health professional before use. 

Keep this and all drugs out of the reach of children. 

If swallowed, get medical help or contact a Poison Control Center immediately (1-800-222-1222).

Directions

 pull down the lower lid of the affected eye and apply a small amount (one-fourth inch) of ointment to the inside of the eyelid, every 3-4 hours or as directed by doctor.

Other Information

 Do not use if bottom ridge of tube cap is exposed, and if imprinted seals on side flaps are not intact and completely legible  store at room temperature 15º-30ºC (59º-86ºF) store away from heat keep from freezing  see crimp of tube or box for lot number and expiration date.

Inactive ingredients 

lanolin alcohols

Questions or comments?

1-888-287-1915

PRINCIPAL DISPLAY PANEL

NDC: 49035-191-50
equate
Restore PM
NIGHTTIME LUBRICANT
EYE OINTMENT
Sterile
NET WT 0.125 OZ (3.5g)

INGREDIENTS AND APPEARANCE

EQUATE RESTORE PM NIGHTTIME LUBRICANT EYE 
mineral oil and petrolatum ointment

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 49035-191
Route of Administration	OPHTHALMIC

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
MINERAL OIL (UNII: T5L8T28FGP) (MINERAL OIL - UNII:T5L8T28FGP)	MINERAL OIL	425 mg  in 1 g
PETROLATUM (UNII: 4T6H12BN9U) (PETROLATUM - UNII:4T6H12BN9U)	PETROLATUM	573 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
LANOLIN ALCOHOLS (UNII: 884C3FA9HE)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 49035-191-50	1 in 1 BOX	03/14/2013
1		3.5 g in 1 TUBE; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC MONOGRAPH FINAL	part349	03/14/2013

Labeler - Wal-Mart Stores, Inc. (051957769)

Registrant - Altaire Pharmaceuticals, Inc. (786790378)